Medical Device Software Risk Analysis
Edwin L Bills
60 Min
Product Id: 700902
This webinar discusses the use of risk analysis techniques applied to medical device software including discussions of pitfalls in the process of risk analysis. This webinar will provide guidance to medical device companies that need to perform risk analysis on their software products and internal systems.
Risk-Based Software V&V - FDA,GAMP®, 14971
John E Lincoln
90 Min
Product Id: 700814
This risk-based software V&V training will guide you through 11 "must have" elements of software validation and how to use your Risk Management Tools (per ISO 14971:2007).
Develop, Execute and Enforce an Effective Validation Master Plan
David Dills
60 Min
Product Id: 700910
Understand why the VMP is a project management tool and why it’s a living, breathing document. This webinar will provide valuable assistance and guidance to all life sciences manufacturers that are preparing to use or are currently using validation master plans to bullet-proof their validation programs.
The CAPA Trap or Common Problems and Pitfalls
Jeff Phillips
60 Min
Product Id: 700914
The following webinar will cover common CAPA problems across industries and how to avoid them. This webinar will provide valuable assistance to all regulated companies that need to have CAPA systems as mandated by the FDA.
How to prepare for the unannounced FDA compliance inspection
Peter Calcott
60 Min
Product Id: 700892
This webinar will walk you through the elements you should plan for, the timing and the logistics of who should do the various components in preparation for the inspection.
Monoclonal Antibodies and Therapeutic Proteins: Designing GLP Compliant Nonclinical Programs to Meet FDA Expectations
Steven S Kuwahara
60 Min
Product Id: 700871
This presentation will cover the GLP requirements for animal studies, and the methods that laboratories employ to comply with the regulations. This webinar will be directed at personnel who must conduct or review the performance of non-clinical laboratory studies related to safety. GLP studies apply to animal studies that are required in all regulated areas.
Virtualization Compliance Assessment (ESX Server and PCI/DSS 1.1)
Michael Hoesing
60 Min
Product Id: 700878
In this presentation each on the categories and requirements of the PCI/DSS standard 1.1 will be compared to settings within the Virtualization configuration of a VMware ESX Server 3.x machine. Security professionals who wish to have a closer look at the security settings possible on a virtualization host for consideration when crafting detailed policies.
Implementing Process Controls for Optimum Performance of Cell-Based Assays
Dr. Wise Blackman
60 Min
Product Id: 700191
Guidance for developing, optimizing, validating and maintaining cells used for cell-based assays using control charts. Bioassays are defined as any biological assay that can be used to show that a product will perform its’ stated function. Due to the nature of bioassays they are inherently variable and require extra care to achieve consistent performance.
Analytical Instrument Qualification-Understanding the New USP draft Chapter
Dr. Ludwig Huber
90 Min
Product Id: 700885
Companies are unsure on what exactly to qualify or re-qualify test and document. The main reason is that unlike for analytical methods there are no clear standards for equipment qualification. The USP has developed a new standard for analytical instrument qualification (AIQ). It will be official by August 1, 2008.
Risk-Based CAPA Systems
John E Lincoln
60 Min
Product Id: 700393
This Corrective and Preventive Action (CAPA) webinar will teach how the risk based approaches be implemented under CAPA.
Lean Documents and Document Control
Jose Mora
90 Min
Product Id: 700331
This webinar presents key concepts on introducing lean principles, while maintaining a state of control and regulatory compliance Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents
IT Infrastructure and Network Qualification- Introduction and Strategies for Compliance and System Uptime
Dr. Ludwig Huber
60 Min
Product Id: 700882
Attend this seminar to learn about proven industry practices for network qualification. Configuration management and change control as the most important network qualification steps.
Hazard Analysis & Risk Management - New 14971
John E Lincoln
90 Min
Product Id: 700813
Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report. The US FDA is increasingly stating that many regulated activities should be "risk-based". Major resource-consuming activities such as product and process / equipment / facility, and software validation, CAPA investigations, vendor audits can all be tailored to a risk based approach.
Legal Issues to Consider When Outsourcing
Kenneth Barden
60 Min
Product Id: 700535
This webinar will focus on various legal issues to consider when your firm outsources its services or operations.
Writing Effective Suspicious Activity Reports
Kenneth Barden
60 Min
Product Id: 700482
The keystone of AML compliance is the reporting to proper authorities of those transactions and activities considered to be suspicious
Human Factors Standards and Guidance's for Medical Devices - which documents apply to my situation?
Robert A North
60 Min
Product Id: 700861
This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device.
Computer System Auditing 21CFR Part 11 Compliance
Richard Poser(PhD)
60 Min
Product Id: 700884
The webinar will address each audit item and train the participants how to determine the compliance status. We will use common examples of non-compliance observations from actual audits and suggest remediation plans that are compliant, efficient and economical.
Ethylene Oxide Sterilizer Validation: Basic Requirements
Mark Dott
Product Id: 700353
This presentation will review the general requirements for performing EO validations via the "overkill" half-cycle method as described in ISO 11135.
Utilizing ICH Guidelines for GCP Regulatory Compliance
Carl Anderson
60 Min
Product Id: 700855
This presentation reviews key ICH guidelines to directly correlate them with FDA Compliance Program Guidance Manuals that FDA investigators use to conduct GCP inspections. This webinar will provide critical assistance to FDA regulated companies currently conducting or preparing to conduct clinical trials.
GLP Compliance Audits: What to look out for at a New Nonclinical CRO
David Pepperl
60 Min
Product Id: 700853
This webinar will discuss how to perform pre-study GLP compliance audits and what to look for at candidate nonclinical CRO This webinar will be valuable for any member of a pharmaceutical or biotechnology organization charged with placing or monitoring nonclinical GLP safety studies.